Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
FDA 510(k) clearance K202467 · decided 2020-12-14
Clearance details
- K-number
- K202467
- Device name
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
- Applicant
- Fengh Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-27
- Decision date
- 2020-12-14
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wuxi, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.